EVS 2023: New data chart underrepresentation of women at the head of national clinical trials

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Valentyna Kostiuk

The underrepresentation of women vascular surgeons in national clinical trial leadership formed the central theme of data coming out of a new study that probed all clinical trials in five main areas of vascular disease between 1997 and 2003. 

Delivered before the 2023 Eastern Vascular Society (EVS) annual meeting in Washington, D.C. (Sept. 7–9), investigators revealed that female vascular surgeons constituted 10.3% of all investigators leading clinical trials, with solo female principal investigators (PIs) making up just 9%. Additionally, only 5% of women vascular surgeons were solo PIs on industry-sponsored trials, and women were also less likely to lead interventional compared to non-interventional treatment trials, EVS 2023 heard. 

The data were presented by Valentyna Kostiuk, a medical student from Yale School of Medicine in New Haven, Connecticut, who opened her talk with a baseline remark: “Female vascular surgeons constitute about 15% of the workforce, but remain underrepresented in vascular societies and NIH [National Institutes of Health] funding. Additionally, female patients are more likely to be enrolled in clinical trials if they are led by female investigators.” 

To evaluate representation, the Yale study group looked at all national PIs, their specialties and their presenting gender. When comparing vascular surgeon PIs to non-vascular surgeon PIs, female investigators constituted 10.3% in the vascular surgeon group compared to 19.9% of investigators in the non-vascular surgical group, Kostiuk said. 

They looked at 114 clinical trials focusing on abdominal aortic aneurysms (AAA), analyzing 101: these were led by 125 vascular surgeons, of which 8.8% were women. Similarly, 138 carotid disease trials were identified, with 122 analyzed. This revealed that 38 were led by vascular surgeons, with 13.2% of them women. Another 100 hemodialysis access trials yielded 86 for analysis. These were led by 52 vascular surgeons (9.6% women). In the venous space, 26 thrombectomy and stenting trials showed 30 vascular surgeon as PIs, with 15.4% of them women. Finally, 536 peripheral arterial disease (PAD) trials yielded 432 for analysis, with 169 headed up by vascular surgeons (10.7% women). 

“Overall, out of all the investigators, for five major vascular conditions, 10% of them were female investigators,” explained Kostiuk. “On subgroup analysis, we looked at clinical trials led by solo PIs, and 9% of these PIs were women. Additionally, women were less likely to lead clinical trials investigating interventions compared to non-interventional treatments. For industry funding, we identified 11% of investigators as women for non-industry sponsored clinical trials as compared to 8% for industry sponsored trials. Out of this 8%, 5% were solo female investigators.” 

Kostiuk concluded by pointing toward the 10.3% figure, which constituted the representation of women vascular surgeons in national clinical trial leadership. “This study identifies a specific issue with diversity and inclusion in our specialty,” she said. “It represents an opportunity for growth and improvement, and also encourages vascular societies and industry sponsors to define pathways for women to lead clinical trials.” 

In response to a query from the EVS audience, Kostiuk said the Yale research team will now look to break down whether the numbers are improving over time or remain stagnant. “The numbers are low and could be improved.” 

Last month, Vascular Specialist reported on the issues surrounding gender representation at the head of clinical trials and female patient enrollment. One of the starkest portraits of the scene was painted by leading vascular surgical voice Melina R. Kibbe, MD, in an interview. 

“We would have fewer untoward side effects, fewer drugs removed from the market by the FDA [Food and Drug Administration], and, ultimately, better outcomes in women,” stated the dean at the University of Virginia School of Medicine in Charlottesville, Virginia, as she reflected on two decades of missed opportunities, the underrepresentation of women as clinical principal investigators (PIs), and women’s under-enrollment as participants in vascular trials. 

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